Surgical Articles and Methods

ABSTRACT

Surgical instruments, implantable articles and surgical procedures disclosed for treating medical disorders, particularly incontinence. Improved surgical sling procedures are disclosed. Novel surgical instruments and kits for use in sling procedures are also disclosed. The present invention affords options for surgeons with concomitant advantages to the patient and the healthcare provider.

PRIORITY

The present application is a continuation of U.S. patent applicationSer. No. 11/202,315 filed Aug. 17, 2006, which is a continuation of U.S.patent application Ser. No. 10/280,945 filed Oct. 25, 2002, which is acontinuation of U.S. patent application Ser. No. 10,005,837 filed Nov.9, 2001, which is a continuation-in-part of U.S. patent application Ser.No. 09/917,443 filed Jul. 27, 2001 and U.S. patent application Ser. No.09/917,562 filed Jul. 27, 2001 and claims priority thereto and of U.S.Provisional Application Ser. No. 60/263,472, filed Jan. 23, 2001; andU.S. Provisional Application Ser. No. 60/269,829, filed Feb. 20, 2001,and U.S. Provisional Application Ser. No. 60/281,350, filed Apr. 4,2001; and U.S. Provisional Application Ser. No. 60/295,068, filed Jun.1, 2001, and U.S. Provisional Application No. 60/306,915, filed Jul. 20,2001; all of whose contents are fully incorporated herein by reference.

BACKGROUND

Urinary incontinence is a significant health concern worldwide.Incontinence may occur when the pelvic floor weakens. There are fivebasic types of incontinence: stress incontinence, urge incontinence,mixed incontinence, overflow incontinence and functional incontinence.There are a large number of surgical interventions and procedures foraddressing incontinence.

Some surgeons are slow to adopt promising new surgical techniques fortreating incontinence for a variety of reasons. Some are untrained orlack experience with the new procedure. Others are simply unwilling totry new instrumentation that seems unfamiliar.

Surgical centers and hospitals have an inventory of surgical instrumentscommonly used in surgery. Surgeons are trained with these stock surgicalinstruments at an early stage and become familiar with them. In theurology field, needles, suture passers and ligature carriers arecommonly available and surgeons often develop significant experience andcomfort with procedures that utilize them. Examples of such surgicalinstruments included Stamey needles, Raz needles, and Pereyra needles.See Stamey, Endoscopic Suspension of the Vesical Neck for UrinaryIncontinence in Females, Ann. Surgery, pp. 465-471, October 1980; andPereyra, A Simplified Surgical Procedure for the Correction of StressIncontinence in Women, West. J. Surg., Obstetrics & Gynecology, pp.243-246, July-August 1959. Some surgeons may reject a new techniquesimply because the instrumentation associated with the technique isunfamiliar.

A variety of surgical procedure options are currently available to treatincontinence. Depending on age, medical condition, and personalpreference, surgical procedures can be used to completely restorecontinence. One type of procedure, found to be an especially successfultreatment option for SUI in both men and women, is a sling procedure.

A sling procedure is a surgical method involving the placement of asling to stabilize or support the bladder neck or urethra. There are avariety of different sling procedures. Descriptions of different slingprocedures are disclosed in U.S. Pat. Nos. 5,112,344; 5,611,515;5,842,478; 5,860,425; 5,899,909; 6,039,686, 6,042,534 and 6,110,101.

Sling procedures differ in the type of material used for the sling, themethod of anchoring the sling material in the body and how the slingmaterial is inserted in the body. The time required for a surgicalprocedure varies, but is preferably as short as possible. This factor isfrequently reported in urology and gynecology literature. See AthertonM. J., et al., A Comparison of Bladder Neck Movement and Elevation AfterTension-free Vaginal Tape and Colposuspension, British Journal ofObstetrics and Gynaecology, November 2000, Vol. 17, p. 1366-1370,Nilsson et al, The Tension-free Vaginal Tape Procedure is Successful inthe Majority of Women with Indications for Surgical Treatment of UrinaryStress Incontinence, British Journal of Obstetrics and Gynaecology,April 2001, Vol. 108, P. 414-419; and Ulmsten et al., An AmbulatorySurgical Procedure Under Local Anesthesia For Treatment of FemaleUrinary Incontinence, Int. Urogynecol. J. (1996), v. 7, pps. 81-86.

Although serious complications associated with sling procedures areinfrequent, they do occur. Complications include urethral obstruction,development of de novo urge incontinence, hemorrhage, prolonged urinaryretention, infection, and damage to surrounding tissue and slingerosion.

The Tension-free Vaginal Tape (TVT) procedure (available from Ethicon,of N.J.) utilizes a Prolene™ nonabsorbable, polypropylene mesh. The meshis a substantially flat, rectangular knitted article. The mesh includesa plurality of holes that are sized to allow tissue ingrowth to helpavoid infection. A plastic sheath surrounds the mesh and is used toinsert the mesh. During the sling procedure, incisions are made in theabdominal (i.e. suprapubic) area and in the vaginal wall. Two curved,relatively large (5 mm or larger) needle-like elements are eachconnected to an end of the vaginal sling mesh. A sling-free, sharp tipend of one of the needle-like elements is initially pushed through thevaginal incision and into the paraurethral space. Using a handleattached to the needle, the needle is angulated laterally (for example,to the right) to perforate the endopelvic fascia, guided through theretropubic space and passed through the abdominal incision. The handleis disconnected and the needle is then withdrawn through the abdominalwall, thereby threading a portion of the sling through the tissue of thepatient. The handle is then connected to the other needle and thetechnique is repeated on the contralateral side, so that the mesh islooped beneath the bladder neck or urethra. The sling is positioned toprovide appropriate support to the bladder neck or urethra. At the endof the procedure, the sling ends are cut at the abdominal wall, thesheath is removed and all incisions are closed.

Complications associated with the TVT procedure and other known slingprocedures include injury to blood vessels of the pelvic sidewall andabdominal wall, hematomas, urinary retention, and bladder and bowelinjury due to passage of large needles. Further, a separate cystoscopyprocedure is usually required in order to confirm bladder integrity orrecognize a bladder perforation after each insertion of the needle-likeelement. One serious disadvantage of the TVT procedure, particularly forsurgeons unfamiliar with the surgical method, is the lack of informationconcerning the precise location of the needle tip relative to adjacentpelvic anatomy. A cadaver study indicated that the TVT needle is placedin close proximity to sensitive tissue such as superficial epigastricvessels, inferior epigastric vessels, the external iliac vessel and theobturator. See, Walters, Mark D., Percutaneous Suburethral Slings: Stateof the Art, presented at the conference of the American UrogynecologicSociety, Chicago (October 2001).

If the TVT needle tip is allowed to accidentally pass across the surfaceof any blood vessel, lymphatic duct, nerve, nerve bundle or organ,serious complications can arise. These shortcomings, attempts to addressthese shortcomings and other problems associated with the TVT procedureare disclosed in PCT publication nos. PCT WO 00/74613 and PCT WO00/74594.

Additional problems are associated with the TVT and other slingprocedures. Removal and reuse of the handle of the TVT product is acumbersome, time consuming process, requiring the surgeon to manuallyrotate the handle until the handle is unscrewed from the needle. Reusingthe handle presents a contamination risk, particularly if the handle andscrew threads are not properly cleaned and sterilized after use on thepatient.

BRIEF SUMMARY

The present invention includes surgical instruments and implantablearticles for urological applications, particularly incontinence surgicalprocedures.

The present invention is also directed to surgical kits for use insurgical procedures for treating incontinence, and improved surgicalprocedures for treating incontinence. The present invention can affordincreased convenience for surgeons with the attendant advantages for thepatient. The present invention can also exploit existing surgeontraining and preferences to contribute to better surgical outcomes.Surgical procedures utilizing the present invention have the capacity tobe shorter with concomitant advantages enjoyed by patients and thehealthcare system.

In one aspect, the present invention comprises a surgical kit orassembly of surgical instruments for treating incontinence comprising animplantable material (e.g. a sling), at least one of a first type ofneedle, and at least one of a second type of needle. The first type ofneedle is different than the second type of needle. For example, oneneedle could be straight and the other curved, or one needle may belarger or longer than the other needle or shaped differently. A varietyof different types of needles are described herein. Providing differenttypes of needles can afford the surgeon options that are unavailablewith existing surgical kits.

The needles in the kit need not serve the same purpose. For example, oneneedle may comprise a relatively small profile (e.g. less than about 3.5mm diameter in cross section) guide needle, and the other needle maycomprise a larger sling transport needle. The guide needle may beinitially inserted suprapubically (e.g. through an abdominal incision)and then guided through a vaginal incision. The larger sling transportneedle can then be associated with the guide needle (e.g. with anoptional adapter or dilator) and then guided upward through the body ofa patient (first through the vaginal incision and then through thesuprapubic incision) by the guide needle.

In another aspect, the invention comprises a kit with a first type ofsling material, a second type of sling material, and at least one needlefor inserting a sling material. The sling materials can comprisesynthetic or non-synthetic sling materials. In one embodiment, the slingmaterials can be both synthetic materials, but different types ofsynthetic materials (e.g. a polypropylene mesh material and a siliconecoated material). There are also many different types of non-syntheticmaterials contemplated herein. Optionally, instead of having anon-synthetic sling material that has short term shelf life relative tothe rest of the elements in the kit, the kit may include an accessory toafford construction of a sling from two different materials. Thisenables the surgeon to customize a hybrid or composite sling fromdifferent materials (e.g. from different packages) to exploit thedifferent properties of the materials and to coordinate them with theintended physiological environment.

Another kit according to the present invention includes an implantablematerial (e.g. a sling), a needle for inserting the sling, and a firstand second type of handle for use in the surgical procedure. A varietyof different types of handles are contemplated herein.

The present invention also includes articles useful in urologicalsurgical procedures. The present invention includes an adaptercomprising a body portion having first and second opposite end portions.The first end portion has surfaces for associating the article with aneedle. The second end portion has a sling associator for associatingthe article with a sling. The sling associator can comprise a universaladapter for connecting a surgical needle with different types of slingmaterials (e.g. synthetic or non-synthetic). The adapter allows thesurgeon to select one of the many options of sling materials availableso that the remaining components of the surgical kit may be utilized toimplant any sling material.

The present invention also includes a needle converter for use with asling assembly having an adapter or dilator. The adapter or dilator hassurfaces for associating with a first type of needle (e.g. a specializedneedle in a kit). The needle converter comprises a first end portionhaving surfaces that are sized and shaped to engage complementarysurfaces in the passageway of the dilator to associate the needleconverter with the dilator. The needle converter has a second endportion that is generally opposite the first end portion. The second endportion has a means for attaching the needle converter to a second typeof needle that is different than the first type of needle. The needleconverter allows the dilator of a sling assembly to be attached with aneedle that is commonly used in surgical procedures for treatingurological disorders (e.g. a Stamey needle). Thus, the needle converterallows a surgeon to connect a sling assembly with a preferred, standardneedle.

The present invention also includes novel slings and sling assemblies.The slings may be conveniently implanted without the use of boneanchors. A sling according to the present invention comprises asynthetic surgical mesh (e.g. polypropylene) having first and secondends and a plurality of holes that are sized and shaped to afford tissueingrowth. The assembly includes a removable synthetic insertion sheathsituated about the surgical mesh. At least one suture is operativelyassociated with the surgical mesh and extends beyond the first end ofthe surgical mesh. At least one other suture is operatively associatedwith the surgical mesh and extends beyond the second end of the surgicalmesh. The sutures are adapted to be associated with a surgical needle.For example, the sutures may be tied to a needle that has a hole in itor placed in a suture passageway of a ligature career.

Another sling according to the present invention comprises a syntheticsurgical mesh (e.g. polypropylene) having a plurality of holes that aresized and shaped to afford tissue ingrowth. The assembly has a removablesynthetic insertion sheath situated about the surgical mesh. The sheathhas first and second ends. At least one suture is operatively associatedwith the insertion sheath and extends beyond the first end of theinsertion sheath. At least one other suture is operatively associatedwith the insertion sheath and extends beyond the second end of theinsertion sheath. The sutures in this embodiment are also adapted to beassociated with surgical needles.

The novel slings may be used in novel surgical procedures according tothe present invention. The novel surgical procedures comprise the stepsof i) providing a novel sling according to the present invention, ii)creating at least one vaginal incision, ii) creating at least onesuprapubic incision, iii) passing a leading end of a needle initiallythrough a suprapubic incision and then through the vaginal incision onone side of the patient's urethra, iv) passing a leading end of a needleinitially through a suprapubic incision and then through the vaginalincision on the other side of the patient's urethra, v) attaching thefirst suture to the leading end of a needle, vi) attaching the secondsuture to the leading end of a needle, vii) implanting the sling bymoving the leading end of a needle from the vaginal incision toward asuprapubic incision, and viii) then removing the synthetic insertionsheath.

Another surgical procedure according to the present invention includesthe use of a plurality of needles with different purposes. A novelsurgical procedure includes the steps of i) providing a surgical kitcomprising at least one guide needle, and at least one sling transportneedle with a tip, a sling attached to the sling transport needle, andan adapter having tip receiving surfaces for receiving the tip of thesling transport needle, ii) creating at least one vaginal incision, iii)creating at least one suprapubic incision, iv) initially passing theguide needle through the suprapubic incision and then through thevaginal incision, v) attaching the adapter to the needle, vi) placingthe tip of the sling transport needle in the tip receiving surfaces ofthe adapter, and vii) guiding the sling transport needle from thevaginal incision to the suprapubic incision with the guide needle toimplant the sling. This procedure allow the surgeon to exploit thecontrol provided by the smaller guide needle to avoid sensitiveanatomical structures while retaining the benefit of the sling transportneedle.

The present invention also includes kits having the novel surgicalinstruments, accessories, articles and slings described herein, andsurgical procedures that utilize the novel structures.

BRIEF DESCRIPTION OF THE DRAWINGS

Other features and advantages of the present invention will be seen asthe following description of particular embodiments progresses inconjunction with the drawings, in which:

FIG. 1 is a top view of a surgical kit according to one aspect of thepresent invention;

FIG. 1A is a top view of a surgical kit according to another aspect ofthe present invention;

FIG. 2 is a perspective view of one embodiment of sling delivery systemof the present invention, showing the sling delivery systemdisassembled;

FIG. 2A is an enlarged perspective view of an optional connector for usein the kit of FIG. 2;

FIG. 2B is a perspective view of a sling constructed from two differentsling materials according to the present invention;

FIG. 2C is a perspective view of a sling having a suture associatedtherewith by means of a suture anchor,

FIG. 3 is a perspective view of a substantially straight needle foroptional use in a kit according to the present invention;

FIG. 4 is a perspective view of a needle with a curved portion foroptional use in a kit according to the present invention;

FIG. 5 is a side view of a needle with first and second handles foroptional use in a kit according to the present invention;

FIG. 6 is a side view of another embodiment of needle for optional usein a kit according to the present invention;

FIG. 6 a is an enlarged side view of a portion of FIG. 6;

FIG. 7 is a side view of another embodiment of needle for optional usein a kit according to the present invention;

FIG. 8 is a side view of an end portion of a needle for optional use ina kit according to the present invention;

FIG. 9 is a side view of another embodiment of needle for optional usein a kit according to the present invention;

FIG. 9A is an enlarged view of a portion of FIG. 9;

FIG. 10 is a side view of another embodiment of needle for optional usein a kit according to the present invention;

FIGS. 11-14 are side views of another embodiment of needle for optionaluse in a kit according to the present invention, wherein

FIG. 11 shows the needle with a blunt member in an unlocked, extendedposition that is extended beyond a sharp surface,

FIG. 12 shows the sharp surface and blunt member as the blunt member isinitially deflected by tissue;

FIG. 13 illustrates the blunt member deflected to substantially thelevel of the sharp surface, such as when the needle encounterssignificant resistance from tissue; and

FIG. 14 shows the blunt member in a locked, extended position after theresistance associated with the tissue ends and a spring has returned theblunt member to the extended position;

FIG. 15 is a side view of a handle and several different embodiments ofneedles adapted for use in the present invention;

FIG. 16 is a top view of the handle and the needles of FIG. 15;

FIG. 17 is an enlarged view of the ends of the needles shown in FIG. 16;

FIG. 18 is a perspective view of an embodiment of an adapter forassociating a needle with a sling according to an aspect of the presentinvention, and portions of a sling assembly or sling;

FIG. 18A is a perspective view showing another embodiment of an adapterfor associating a needle with a sling according to an aspect of thepresent invention, and an end portion of a needle;

FIG. 18B is a side view of another embodiment of an adapter forassociating a needle with a sling according to an aspect of the presentinvention, and portions of a sling or sling assembly;

FIG. 19 includes perspective views of various optional handles foroptional use according to the present invention;

FIG. 20 is a side view of a needle with an optional strengthening handlefor use in an aspect of the present invention;

FIG. 21 is a perspective view of another embodiment of sling deliverysystem of the present invention, showing the sling delivery systemdisassembled;

FIG. 21A is a perspective view showing a sling constructed from amaterial different than the material shown in FIG. 21;

FIG. 21B is a side view of a suture anchor for use in an optional slingaccording to the present invention;

FIG. 22 is a top view of a sling assembly according to an aspect of thepresent invention;

FIG. 22A is a top view of a sling assembly according to another aspectof the present invention;

FIG. 23 is a perspective view of one embodiment of an adapter forassociating a needle with a sling according to an aspect of the presentinvention;

FIG. 24 is a top view of the adapter of FIG. 23 shown sutured to a slingassembly;

FIG. 25 is a side view of the adapter of FIG. 23 and a suture threadedthrough a passageway in the adapter and through a sling anchor on anon-synthetic sling;

FIG. 26 is a sectional view of the adapter of FIG. 23;

FIG. 27 is a side view of a sling assembly, needle converter and needlein a disassembled condition;

FIG. 27A shows the elements of FIG. 27 in an assembled condition;

FIG. 28 is a flow chart showing a process according to an aspect of thepresent invention;

FIG. 29 is a flow chart showing another process according to anotheraspect of the present invention;

FIGS. 30 through 33 are perspective views sequentially showing theinsertion of a needle suprapubically in accordance with one aspect ofthe present invention, wherein:

FIG. 30 shows the needle just passing an abdominal incision;

FIG. 31 illustrates the needle as the surgeon seeks to identify thetactile feel of the resistance provided in part by the posterior portionof the pubic bone;

FIG. 32 shows the needle as it passes along the posterior surface of thepubic bone which may be used as an anatomical guide for a surgeon as theneedle approaches a vaginal incision;

FIG. 33 illustrates the needle as it passes out of a vaginal incision;

FIG. 34 is a perspective view of a sling system attached to two needlesaccording to an embodiment of the present invention;

FIG. 35 is a perspective view of a sling assembly being pulled upward bya needle in accordance with the present invention,

FIG. 36 is a perspective view of the sling according to the presentinvention after the adapters have been separated from the rest of theassembly, but prior to final trimming;

FIG. 37 is a perspective view of the sling according to the presentinvention after the sheath has been removed and the sling has beentrimmed;

FIG. 38 is a perspective view of a small guide needle after it has beeninserted suprapubically, an adapter connected to the small guide needleafter the needle has been inserted suprapubically, and another largeneedle for implanting a sling that is inserted in an open end of theadapter in preparation for being guided through the patient by the smallneedle;

FIG. 39 is a perspective view of an accessory for use in a kit accordingto the present invention;

FIG. 40 is a perspective view of another needle according to the presentinvention that includes a schematic depiction of a feature of theneedle;

FIG. 41 is a side view of another embodiment of adapter and slingmaterial according to the present invention; with the elements shown ina disassembled condition;

FIG. 42 is a side view of another embodiment of adapter and a slingmaterial according to another aspect of the present invention; and

FIG. 43 is a side view of the elements of FIG. 41 with the elementsshown in an assembled condition.

DETAILED DESCRIPTION

The following description is meant to be illustrative only and notlimiting. Other embodiments of this invention will be apparent to thoseof ordinary skill in the art in view of this description.

The present invention is directed to surgical instruments, andimplantable articles for treating medical disorders such as incontinenceor stress urinary incontinence (SUI) in both men and women. The presentinvention is also directed to improved surgical procedures that utilizethe surgical articles. Although the invention as disclosed hereingenerally refers to SUI, treatment of other urological disorders, suchas urge incontinence, fecal incontinence, mixed incontinence, overflowincontinence, functional incontinence, prolapse (e.g. vaginal anduterine), enteroceles (e.g. of the uterus or small bowel), rectoceles,cystoceles and other disorders are also included within the scope of thepresent invention. It is contemplated that the present invention mayalso be utilized in conjunction with concomitant procedures, such as,but not limited to, procedures for addressing cystocele, rectocele,vaginal prolapse and anatomic corrections.

In one aspect, the present invention comprises a surgical kit. FIG. 1Aillustrates an example of such a kit 15. The kit 15 comprises animplantable material (e.g. a sling mesh provided as part of a slingassembly 46), at least one (preferably two) samples of a first type ofneedle 60, and at least one (preferably two) of a second type of needle60A. The first type of needle 60 is preferably different than the secondtype of needle 60A.

As used herein, the term “needle” is used generally to describe avariety of surgical instruments including suture passers, ligaturecarriers, needles and the like. Typically, the needle will have anelongate body and a pair of ends. The needle facilitates passage throughtissue, preferably from an abdominal incision to a vaginal incision or,alternatively from the vaginal incision to an abdominal incision. Asused in this application, when it is said that one needle is of adifferent type than another needle, it is meant that the needlessubstantially differ in a feature that can potentially affect a surgicalprocedure for treating a urological disorder. Features that can bedifferent according to the present invention include, but are notlimited to the size of the needles, the length of the needles, the shapeof the needles, the characteristics of an end of the needles (e.g. sharpor blunt surfaces, closed or open lumen), the capacity of the needle tooperate with a bladder perforation detector or a means for avoidingperforations of the bladder, the material of the needles, whether theneedles have the capacity to be tied to a suture, the strength of theneedles, the cross sectional size (e.g. diameter) or shape of theneedle, the presence of an integral handle, the presence of a bladderperforation detection feature, the degree that the needles aremalleable, whether the needles are reusable or only provided for use ona single patient, the capacity of the needles to be sterilized by aparticular sterilization procedure, whether the needles have surfacesthat are sized and shaped to engage complementary surfaces on anothersurgical article, the capacity of the needle to deliver a medicamentsuch as an anaesthetic, the capacity of the needle to include a lightingfeature, whether the needles have a portion that is movable relative toremaining portions of the needle, and other features.

FIG. 4 illustrates a curved needle 60. The needle 60 is preferablyarc-shaped and includes end 58 and end 62. The ends or tip of the needle60 are preferably not sharp, but may be tapered to afford easy passagethrough tissue while providing a blunt surface that avoids cuttingsensitive tissue such as the bladder or urethra. In a preferredembodiment, the length of the needle 60 is approximately within therange of 16.5 cm to 24.1 cm (6.5 inches to 9.5 inches) and has apreferred external diameter of approximately 3.175 mm (0.125 inch).Preferably, the diameter of the needle 60 is small relative to the priorart to reduce tissue trauma.

The needle 60 is preferably made of a malleable, yet durable,biocompatible surgical instrument material such as, but not limited to,stainless steel (e.g. 316 stainless steel or 17-4 stainless steel),titanium Nitinol, polymers, plastics and other materials, includingcombinations of materials. The needle 60 should have sufficientstructural integrity to withstand the various forces (e.g. forces causedby dilator attachment, and penetration/passage of the needle 60 throughthe various tissues) without undergoing any significant structuraldeformation. Optionally, the needles 60 could be sufficiently malleableto allow a practitioner or user of the device to modify the needle 60 toa desired shape and, thereby, optimize the procedural approach.

FIG. 3 illustrates a substantially straight needle 60A. Some surgeonsprefer a curved needle to a straight needle for some urologicalprocedures. Others prefer straight needles to curved needles. Providingthe surgeon the option to use either needle from a surgical kit canincrease the convenience for the surgeon and can match the skillspossessed by a particular surgeon with the surgical instrumentationprovided in the surgical kit.

FIG. 6 illustrates a different type of curved needle 40 with integralhandle 44. The leading end portion 42 of the needle 40 includes apassageway (hole 42) for receiving a suture 6 used during the surgicalprocedure. FIGS. 7 and 8 illustrate a curved needle assembly 50 with acurved portion 53, an end 54, a movable handle 52 and a handle lock orstabilizer 51.

FIGS. 9, 9A and 10 show a different type of needle assembly 80comprising an end portion 81 with a passageway 82 for receiving a suture6. The passageway 82 for receiving a suture 6 is illustrated as a hole.Alternatively, the passageway could include a slot, slit or other shapefor receiving and securely grasping the suture 6.

The needle assembly 80 includes shaft 87. The end portion 81 andpassageway 82 are placeable within the sheath 87. Preferably the endportion 81 is blunt and free of any sharp surfaces. The needle 80 alsoincludes a mechanism 85 that is capable of moving the blunt end portion81 between i) an extended position with the suture passageway 82extending beyond the end of the outer sheath member 87 so that thesuture passageway can conveniently receive a suture 6, and ii) aretracted position with the blunt end portion spaced closer to the endof the outer sheath member 87 than in the extended position and forsecurely holding a suture placed within suture passageway 82.Preferably, in the retracted position, the passageway 82 is completelywithin the sheath member 87 to securely hold the suture 6 to the needle80 and to resist separation of the suture 6 and needle 80. A button 88is used to conveniently move the elements between the extended andretracted positions. Preferably, a spring is utilized to bias theelements toward the retracted position.

FIGS. 11-14 illustrate another embodiment of needle 500 for optional usein a kit according to the present invention. The needle 500 includes ahandle and a sheath that remain relatively stationary. The sheathincludes a relatively sharp surface 518 for cutting tissue. The needle500 also includes an inner member that is movable relative to thehandle. The inner member has a blunt end 528. Preferably, the movablemember also includes a suture passageway 529. Alternatively, the innermember could include a means for snapping onto a dilator as describedmore fully below.

FIG. 11 shows the needle 500 with a blunt member 528 in an unlocked,extended position that is extended beyond sharp surface 518. In thisposition, the blunt member 528 protects tissue from the sharp surface518 but the blunt member 528 is free to deflect inwardly when the needleis pressed against tough tissue (e.g. abdominal fascia). FIG. 12 showsthe sharp surface 518 and blunt member 528 as the blunt member 528 isinitially deflected by tissue.

FIG. 13 illustrates the blunt member 528 deflected to substantially thelevel of the sharp surface 518, such as when the needle encounterssignificant resistance from tissue. In this condition, the sharp surfacemay now be exploited to cut through the tough tissue to avoid the suddenneedle lurch associated with a blunt ended, prior art needle. FIG. 14shows the blunt member 528 in a locked, extended position after theresistance associated with the tissue ends and spring 510 has returnedthe blunt member 528 to the extended position.

Preferably, the needle 500 has a locking means for locking the blunt endportion 528 in the extended position to avoid injuring tissue once theneedle passes through the tough tissue. The locking means preferablycomprises a locking leaf spring 502. One end of the leaf spring 502 ispreferably attached to the handle and the other end of the leaf spring502 is movable between a locking position (FIG. 14) and a releaseposition (FIGS. 11-13).

The inner movable member with blunt end 528 includes a spring shoulder509, and extension arm 530 with leaf spring cam surface 537 and blockingsurface 532. When the needle 500 is initially pressed against the tissueto be cut, the leaf spring cam surface 537 cams the end of the leafspring 502 off of a retaining lip 520 (described in more detail below).The blocking surface 532 is adapted to engage the end of the lockingleaf spring 502 to lock the movable member in the extended position.Spring 510 biases the inner member toward the extended position. Afloating spring attachment member is operatively associated with one endof the spring 510 and the other end engages spring shoulder 509 of theinner movable member.

The needle 500 also preferably includes a release mechanism forreleasing the inner member with blunt end 528 from the locked position.The release mechanism includes a slidable button 525 assembly with aleaf spring retaining lip 520. The leaf spring retaining lip 520 issized and shaped to retain the leaf spring in the release position shownin FIG. 11. The release mechanism also includes a deflection surface(just adjacent retaining lip 520) to move the leaf spring from thelocked position. (FIG. 14) to the release position (FIG. 11) when thebutton 525 is pressed.

FIGS. 15 through 17 illustrate additional examples of different types ofneedles for use in a kit according to the present invention. Needle 202includes two substantially straight portions situated at a predeterminedangle. The needle 202 has two substantially disc shaped integralhandles, and a diamond-shaped, substantially flat end portion. The endportion includes a passageway. Needle 204 has two substantially straightportions at a predetermined angle that is different than the angle ofneedle 202. Needle 204 is also longer than needle 202 and has adifferent shaped end portion. Needle 206 has a straight and a curvedportion. Needle 206 includes a substantially flat end portion with apassageway 208. A handle 200 with a set screw may be attached to theneedle 206 (e.g. at complementary surface 209).

Needles 202, 204 and 206 are sized and shaped to be suitable for use insurgical procedures. The needles are particularly useful for treatingurological disorders. Preferably, the needles are constructed from astrong biocompatible material such as stainless steel. They may bereusable and can be sterilized by steam sterilization procedures,including flash sterilization procedures commonly located close to thesurgical location.

The different sizes and shapes of the needles provide a surgeon with theoption to use a different needle depending upon the needs of aparticular surgical procedure (e.g. size of the patient, previoussurgical procedures, scarring, concomitant procedures, condition of thepatient, and the anatomy of the patient, etc.).

In another aspect of the present invention, the different types ofneedles need not serve the same purpose in a surgical procedure, butcould serve a different purpose. FIG. 38 illustrates a surgical guideneedle 602 (e.g. with a diameter of about 4 mm, or less, preferablyabout 3 mm) and a relatively larger sling transport needle 604 (e.g.with a diameter of 5 mm). Preferably, the sling transport member has asling assembly 610 (e.g. a sling mesh and insertion sheath) attachedthereto.

The guide needle 602 serves a different purpose than the surgicaltransport needle 604. The surgical guide needle 602 is preferably smalland has a blunt tip. The blunt tip is initially inserted through anabdominal or suprapubic incision 400 and then through a vaginal incision404. Inserting a small, blunt needle in this fashion provides thesurgeon with addition control in maneuvering through the anatomy of apatent and in avoiding sensitive tissue.

A surgical kit according to an aspect of the present invention mayinclude an adapter 54 on the end of needle 602. The sling transportneedle 604 may optionally include a sharp tip. The adapter receives thetip of the needle 604. Pushing upward on the sling transport needle 604with one hand while steering the tip of the needle 604 by holding guideneedle 602 with the other hand is believed to provide better controlover insertion of a prior art large needle that is initially insertedthrough the vaginal incision 404 and then through the suprapubicincision.

Alternatively, the adapter can include surfaces for firmly engaging andattaching to needle 604. Those surfaces can include mechanicalinterlocking structures, grasping structures or interlocking structures.Optionally, a biocompatible adhesive may be used to adhere the tip ofsling transport needle 604 to the adapter.

FIG. 40 illustrates a needle 60 with a bladder perforation detector 121.A variety of means may be used as the bladder perforation detector. Theneedle perforation detector can include a ph sensor for determiningwhether the ph encountered by the needle is outside anticipated limits.For example, if the bladder has been perforated, fluid associated withsuch a perforation is likely to encounter the end 58 of the needle andchange the ph encountered by the needle. The change in ph can be used tosignal that the bladder has been perforated.

The bladder perforation detector 121 preferably signals an impendingbladder perforation prior to its occurrence so that it prevents bladderperforations. For example, an object may be placed in the bladder 14 ofthe patient. The needle 60 and object can have complementary lightsource and detection means (e.g. a photoelectric sensor) for avoidingbladder perforations by the end 58 of the needle 60. For example, theobject can include a light source and a light emitter. The needle 60 caninclude a light detector tuned to receive light emitted from the object.Preferably, the object emits light through the bladder 14 so that theneedle 60 detects the light prior to perforating the bladder 14.

Alternatively, needle 60 may be associated with a light source and canemit light. In this embodiment, the object placed in the bladderincludes a photosensitive detector/receptor and can be associated withan alarm and controller. The controller can set a threshold of lightintensity detected. Above that threshold, an alarm may be used to warn asurgeon that the needle is in proximity to the bladder and that abladder perforation may be impending. Optionally, the bladder may befilled with a photoconductive medium to enhance bladder perforationdetection.

In another embodiment, the needle can have a resistance or capacitancedetector capable of detecting the change in resistance encountered afterthe bladder is perforated. In another embodiment, an object can beplaced in the bladder through the urethra. The needle can include aproximity sensor for detecting the proximity of the needle to theobject. This type of needle can be constructed to be operativelyassociated with an alarm mechanism (e.g. audible, visual or tactile)that informs the surgeon that the needle is in proximity to the objectthat is placed in the bladder. Such a device is believed to avoidbladder perforations as, upon sensing the alarm, the surgeon may changethe path of the needle to a path that is away from a close proximity tothe bladder. Alternatively, the proximity of the needle and an object inthe bladder can close a circuit and actuate an alarm. The alarm may beaudible, visual or tactile to the user by an integral part of the needleor a separate device integrated into the system.

In another aspect of the present invention, a needle may optionallyinclude the capacity to deliver a medicament (e.g. anesthesia) duringthe surgical procedure. For example, the needle may be hollow with anopen end. The needle may have a connector for associating with amedicament reservoir and delivery mechanism (e.g. a syringe). As anotheralternative, the needle may comprise a means for connecting to a lightsource to enhance visibility or for being monitored by a light detectorplaced in the bladder (e.g. to avoid bladder perforations).

Referring to FIG. 1, in another aspect the present invention comprises asurgical kit 11 comprising a first type of sling material (e.g. as partof the sling assembly 46), a second type of sling material 10, and atleast one needle (e.g. 60). As used herein, the terms “sling” or“article” or “mesh” or the phrases “implantable material” or“implantable article” or “sling mesh” (or combinations thereof) are usedgenerally to describe a variety of materials including synthetic andnon-synthetic materials. Typically, the implantable article will beelongate and substantially flat. It can be used as a hammock, sling,strip or support member. As used in this application, when it is saidthat one sling material is of a different type than another slingmaterial, it is meant that the materials substantially differ in afeature that can potentially affect a surgical procedure for treating aurological disorder. Features that can be different according to thepresent invention include, but are not limited to the ability of thesling to avoid infections or tissue erosion, the shelf life of theproduct, the type of material, the shape of the material, the presenceof a sling tensioning member (e.g. as disclosed in U.S. patentapplication Ser. No. 09/917,562, filed Jul. 27, 2001), the present of asling adjustment feature as described in U.S. patent application Ser.No. 10/004,185 filed Oct. 30, 2001, now U.S. Pat. No. 6,648,921 whichclaims priority to U.S. Provisional Application No. 60/237,075 filedOct. 3, 2001, sling material treatment, the porosity of the slingmaterial, the shape of the sling material, the sling length, thestrength of the material, the elastic property of the material, thepotential for tissue ingrowth, the biocompatibility of the material, andthe presence or absence of an insertion sheath.

While the slings are preferably rectangular for treating SUI in females,other shapes are also contemplated. Depending on the treatment addressed(e.g. to provide hammock support for the bladder or bladder neck, or toaddress a rectocele, enterocele or prolapse) the slings may be any of awide variety of shapes. As an example, the sling may be of the generalshape of the slings described and shown in Moir et al., TheGauze-Hammock Operation, Journal of Obstetrics and Gynaecology of theBritish Commonwealth, Volume 75, No. 1, Pps. 1-9 (1968).

Suitable non-synthetic materials include allografts, homografts,heterografts, autologous tissues, cadaveric fascia and fascia lata. Somesurgeons believe that non-synthetic materials are i) more consistentfrom lot to lot in terms of material characteristics, as opposed to somesynthetic slings whose characteristics may be believed to vary, ii) lesslikely to cause tissue erosion or are less likely to elicit an adversereaction from the patient's foreign body response mechanism as the bodyis less likely to recognize a non-synthetic material as a foreignmaterial, and iii) are less likely to be rejected by the body long term.

Suitably synthetic materials for a sling include polymerics, andplastics and any combination of such materials may also be used in a kitof the present invention. Commercial examples of such materials includeMarlex™, Prolene™, and Vaskutek™. Other examples of suitable materialsinclude those disclosed in U.S. patent application Ser. No. 09/939,098filed Aug. 24, 2001 (the entire contents of which are hereinincorporated by reference). Specific examples of synthetic slingmaterials include, but are not limited to polypropylene, polyethylene,nylon, PLLA and PGA. For example, some surgeons prefer syntheticmaterials because they believe such materials: i) are stronger and/ormore durable than many non-synthetic materials (e.g. less likely toexperience suture detachment failure), ii) have different elasticproperties, iii) are more likely to afford desirable tissue ingrowth,iv) can be readily and effectively incorporated with desirable featuressuch as antimicrobial agents, v) many non-synthetic sling materials aredifficult to acquire, and vi) present no issues of cross contaminationbetween species.

The sling material may be resorbable, absorbable or non-absorbable.Optionally portions may be absorbable and other portions may benon-absorbable.

In one aspect of the invention, the sling may comprise a mesh material.The mesh material comprises one or more woven, knitted or inter-linkedfilaments or fibers that form multiple fiber junctions throughout themesh. The fiber junctions may be formed via weaving, knitting, braiding,bonding, ultrasonic welding or other junction forming techniques,including combinations thereof. In addition, the size of the resultantopenings or pores of the mesh may be sufficient to allow tissuein-growth and fixation within surrounding tissue. As an example, notintended to be limiting, the holes may comprise polygonal shaped holeswith diagonals of 0.132 inches and 0.076 inches. Holes much smaller thanthis are not preferred as they may facilitate bacterial colonization.

The quantity and type of fiber junctions, fiber weave, pattern, andmaterial type influence various sling properties or characteristics.Non-mesh sling configurations are also included within the scope of theinvention. As another example, not intended to be limiting, the mesh maybe woven polypropylene monofilament, knitted with a warp tricot. Thestitch count may be 27.5 courses/inch (+ or −2 courses) and 13wales/inch (+ or −2 wales). The thickness of this example is 0.024inches.

In another embodiment the sling material may have one or more substancesassociated therewith through a process such as coating. Examples ofappropriate substances include, without limitation, drugs, hormones,antibiotics, antimicrobial substances, dyes, silicone elastomers,polyurethanes, radiopaque filaments or substances, anti-bacterialsubstances, chemicals or agents, including any combinations thereof. Thesubstances may be used to enhance treatment effects, reduce potentialsling rejection by the body, reduce the chances of tissue erosion,enhance visualization, indicate proper sling orientation, resistinfection or other effects. For example, the sling may be coated by theprocess described in U.S. Pat. Nos. 5,624,704; 5,756,145; 5,853,745;5,902,283 and 6,162,487 (the entire contents of which are herebyincorporated by reference).

FIG. 2 illustrates a sling assembly comprising sling 42 and sheath 44that are made of biocompatible materials having sufficient strength andstructural integrity to withstand the various forces exerted upon thesecomponents during an implant procedure and/or following implantationwithin a patient.

Preferably, the overall dimensions of the sling assembly 46, includinginsertion sheath 44 and sling 42 are sufficient to extend from anabdominal incision, to an undersurface of the urethra and back toanother abdominal incision with additional size to account for theimprecision associated with the range of human anatomy sizes. In apreferred embodiment, the sheath length of the assembly of the presentinvention is approximately within the range of 52.0 cm to 58.5 cm (20.5inches to 23.0 inches), sheath width is approximately within the rangeof 1.0 cm to 1.63 cm (0.482 inch to 0.642 inch) and sheath materialthickness is approximately within the range of 0.127 mm to 0.203 mm(0.005 inch to 0.008 inch), respectively. The associated sling 42 has alength, width and thickness approximately within the range of 40 cm to51 cm (15.7 inches to 20.1 inches), 1.0 cm to 1.2 cm (0.394 inch to0.472 inch) and 0.508 mm to 0.711 mm (0.020 inch to 0.028 inch),respectively.

The sling 42 of the present invention can be implanted without the needfor bone screws. Upon implantation, a portion of the sling 42 is passedand/or woven through various layers of abdominal/pelvic tissue.

The sling 42 is designed to remain within the body of a patient as animplant for a predetermined therapeutically effective amount of time.The sling may be non-absorbable, absorbable or resorbable, including anycombinations of these material properties, depending on the desiredtreatment. The general characteristics of the sling material and designshould be such as to withstand the various forces exerted upon it duringimplantation (for example, frictional forces associated with tissueresistance) and after implantation (for example, increased abdominal orbladder pressure caused by a stress event).

The precise, final location of the sling 42 will depend on a variety offactors including the particular surgical procedure(s) performed, andany preconditions of the patient such as scar tissue or previoussurgeries. For example, it may be preferred to place the sling 42 inclose proximity to, but not in contact with, a mid portion of theurethra to treat incontinence.

In another aspect, the present invention includes an element thataffords construction of a hybrid sling from different types of slingmaterials. FIG. 2 shows a sling constructed from a synthetic material42. FIG. 2B illustrates a sling constructed from a synthetic material 42and a non-synthetic material 10. FIG. 2C shows a sling assemblyconstructed from a non-synthetic material 10. The connector 8 shown inFIG. 2A may be used to connect one type of sling material 10 to anothertype of sling material 42 or to connect a sling with a needle. Anysuitable biocompatible structure may be used as the connector 8. Forexample, one or more of the connectors described in U.S. patentapplication Ser. No. 09/749,301, filed Dec. 27, 2000, entitled“Apparatus and Methods For Enhancing the Functional Longevity and ForFacilitating the Implantation of Medical Devices” (the entire contentsincorporated herein by reference) may be used.

Referring to FIG. 2, the connector 8 may be used to attach a loop 48 ofsheath 44 to a dilator 54 (described more fully below) or the connector8 may be used to operatively associate a suture 6 with the slingassembly 46. The suture 6 may then be used to attach the sling assembly46 to needle 60 or another type of needle.

In use, a particular surgeon may prefer to place non-synthetic material(e.g. 10) in the mid portion of the sling, believing that such a slingis less likely to erode the urethra of a patient. That surgeon may alsodesire to have synthetic materials along the end portions of the sling,believing that such synthetic end portions are more likely to anchor intissue and promote tissue ingrowth. In another alternative, a surgeonmay construct a silicone coated synthetic sling material in the midportion of the sling to avoid tissue erosion and a polypropylene meshmaterial along the end portions of the sling.

The connector 8 allows the hybrid sling to be constructed just prior tothe surgical procedure so that it may be customized for a particularsurgical procedure. A customized sling can account for factors such aspre-existing scarring, patient anatomy size and the intended use for thesling (e.g. to raise the bladder neck or to merely support it). It canalso be constructed to be complementary to concomitant procedures (e.g.for addressing a prolapse). The connector 8 can be made of Delrin, ABS,nylon, polycarbonate, acetal, polyetherimide, polysulfone or othersterilizable materials.

Other elements may be used as a means for constructing a hybrid slingfrom a first type of sling material and a second type of sling material.For example, a biocompatible adhesive or sealant (e.g. a tissue adhesiveor sealant) may be used. The biocompatible adhesive may comprise any ofthe adhesives, sealants and implantable materials disclosed orreferenced in U.S. Provisional Patent Application Nos. 60/302,929 filedJul. 3, 2001, and 60/307,836 filed Jul. 25, 2001, and 60/325,870 filedSep. 28, 2001 (the entire contents of which are herein incorporated byreference). Additional commercial examples of such adhesives, sealantsand implantable materials include Tissuebond and Tissuepatch availablefrom Tissuemed, RapiSeal from Fusion, CoStasis from Cohesion andFocalSeal from Focal.

According to one embodiment, the sling may include a protective sheath44 (see FIG. 2). The sheath 44 is used during insertion of the strip 42.After the sling 42 is implanted, the sheath 44 is removed and discarded.Preferably, the protective sheath 44 is constructed of a material thataffords visual examination of the implantable sling material 42 and thataffords convenient passage of the assembly 46 through tissue of thepatient.

In a preferred embodiment, the sheath 44 is made of polyethylene. Othermaterials including, without limitation, polypropylene, nylon, polyesteror Teflon may also be used to construct the sheath 44. The sheathmaterial should be flexible and provide sufficient structural integrityto withstand the various forces exerted on the sheath 44 throughout thesling delivery procedure. In general, the sheath 44 is configured tohave sufficient flexibility to facilitate user manipulation and adequatestructural strength to withstand the various forces applied to thesheath 44 during delivery and/or positioning of the sling assembly 46.It should also conveniently separate from the sling material 42 afterthe sling 42 is implanted without materially changing the position ofthe sling 42.

The sheath 44 may comprise two elongate, separable sections. Optionally,portions of the sheath 44 may detachably and telescopically overlap nearthe middle portion of the sling. In addition to resisting sling exposureand contamination, the overlapping section may also be used as a visualindicator for the practitioner or user of the device. Additionally,orientation indicia (not shown) may be placed on the overlapping portionto indicate proper orientation of the sling relative to the urethra.Alternatively, other configurations of the sheath 44 are within thescope of the present invention. In particular, the sheath may be unitaryas opposed to telescoping with perforations, slits, holes, scores ortear lines designed to allow separation and removal of the sheath 44.

During sheath removal, the first section and the second section of thesheath are slid off the sling 42 by pulling each end of the sheath 44away from the middle portion of the sling assembly 46. Removal of thesheath 44 causes separation of the overlapping sheath sections, therebyexposing the sling 42. In addition, the smooth outer surface of thesheath 44 provides a relatively frictionless surface to facilitatepassage of the sheath 44 through the various tissues. The relativelyfrictionless motion also avoids disturbing the position of the sling 42relative to the anatomy of the patient.

In another embodiment of the invention, the sheath 44, or a portionthereof, is associated with one or more substances including thosesubstances identified with respect to sling 42. The substances may beused to enhance sheath removal, identify twists along the sheath 44 (andthereby indicate proper sling orientation), indicate cutting/separationpoints, indicate center-point, resist infection or provide otherdesirable effects. For example, a first surface of the sheath 44 mayinclude indicia that should lie opposite the urethra or bladder neck toensure proper sling orientation. Thus, the indicia provide thepractitioner/surgeon with a visual indicator to aid in properlyorienting the sling assembly 46, and ultimately the sling 42, within thepatient.

In another aspect, the present invention comprises an article (e.g. 54,FIG. 2) for use in a surgical sling procedure. The article 54 comprisesa body portion having first end portion 56 and second end portion 52opposite the first end portion 56. The first end portion 56 has surfacesfor associating the article 54 with a needle (e.g. end 58 of needle 60).The second end portion 52 has sling association means for associatingthe article with a sling. The sling association means may comprise ahole 90.

Preferably, the article 54 comprises a dilator that dilates a needletrack for ease of sling introduction and positioning within the patient.End 58 of the needle 60 is preferably keyed to allow for convenient,secure attachment of the needle 60 relative to the dilator 54. In apreferred embodiment, the key feature prevents rotation of the dilator54 relative to the needle 60.

The kits shown in FIGS. 1, 1A and 2 include two dilators. The dilator 54atraumatically creates and/or expands the passageway through the tissuesfor sling assembly delivery. The dilator 54 is preferably short relativeto a needle 60 for ease of passage of the assembly and to reduce theoverall amount of tissue that is deflected at one time. Preferably, thedilator is less than 2.5 inches in length, and more preferably, it isless than one inch in length. The maximum radius of a dilator 54 ispreferably less than 10 mm, more preferably less than 7.5 mm, even morepreferably less than 5 mm. The tip of the dilator 54 is preferablyblunt, as, in preferred embodiments, the leading tip of the dilator 54will pass through tissue that has already been pierced by a needle 60.

The dilator 54 may be made from a variety of biocompatible andsterilizable materials including, without limitation, acetal, Delrin™,Acrylonitrile-Butadiene-Styrene (ABS), polyethylene, nylon and anycombination of biocompatible materials.

The dilator 54 preferably includes means for associating with a surgicalneedle 60. In a preferred embodiment, the association means affords apermanent affixation between the dilator 54 and the needle 60. By“permanent affixation”, it is meant that it would be very difficult tomanually separate the dilator from the needle after they have becomepermanently affixed. After implantation of the sling 42, to separate thesling 42 from the dilator 54/needle 60, the surgeon cuts an end of thesling 42 as described more fully below. The association means preferablyaffords quick and convenient attachment of the dilator 54 to the needle60 to avoid wasting time in the midst of a surgical procedure. Theattachment should also be secure to avoid separation of the needle 60and dilator 54 while the combination is passed through tissue.

As seen in FIGS. 4 and 18A, the first and second ends 58 and 62 of theneedle 60 may include a keying feature affording secure associationbetween the needle and dilator 54 and/or sheath assembly 46. In oneembodiment, the keying feature comprises a recess 130 and/orsquare-shaped portion 126. As previously described, the recess 130 andsquare-shaped portion 126 are designed for complementary engagement tothe appropriate end of a dilator 54. Alternatively, a suture 6 maysimply be tied to the recessed portion of the end of the needle 60.

The dilator 54 also includes a universal sling association means (e.g.hole 90) for associating with the surgeon's choice of sling. Optionally,the dilator 54 may be preattached to the sling 42 and/or sheath 44,particularly if the sling is a synthetic material. Alternatively, thesynthetic sling 42 can be cut and removed from dilator 54, and thedilator may be attached to a non-synthetic sling material (e.g.cadaveric or autologous sling material) just prior to sling placement.

Referring to the embodiment of dilator shown in FIGS. 23-26, the dilator54 may be approximately 3.1 cm (1.2 inches) in length. The dilator 54preferably includes a gentle taper 88 near its first end 56. The dilatoris sized and shaped to provide atraumatic passage through body tissue.The taper 88 and relatively smooth outer surface of the dilator 54facilitate atraumatic passage of the dilator 54 and attached slingassembly 46 through the various tissues of the patient. The presence ofthe dilator 54 allows a gentle transition between the diameter of theneedle, to the shape of the dilator, and finally to the sling assembly46, as opposed to prior art assemblies, where the structure of the slingassembly abruptly increases the profile of the needle and thereby thesize of the structure that must pass through tissue.

Preferably, the second end 52 of the dilator 54 associates the dilatorwith one end of a sling 42, or sheath 44 or sling assembly 46. Thesheath 44 or sling 42 is preferably attached to the dilator 54 via afirst opening or through-hole 90 located near the second end of thedilator 54. In this embodiment, the opening 90 operates as a universalsling material or assembly attachment point which can receive a varietyof materials, such as fascia, autologous materials, synthetics, biologictissues and any other similar tissues, including any combinations.

FIG. 21 illustrates a first sling 42 constructed of synthetic materialwith a plurality of through holes and a suture 6 threaded through a holein synthetic material 42 that is spaced from the end of the syntheticmaterial 42. FIG. 21A shows a non-synthetic sling material 3 with asuture anchor 7 attached thereto. The suture anchor 7 firmly associatesthe sling 3 with the suture 6 and resists separation of the sling 3 andthe suture 6. Either sling material 3 or 42 can be convenientlyassociated with dilator 54 by threading suture 6 through hole 90 andtying the suture. In this fashion the dilator/adapter 54 can universallyconnect to either a synthetic (e.g. polypropylene) mesh 42 or anon-synthetic sling (e.g. cadaveric fascia 10).

In the embodiment shown in FIG. 2, the end portion 48 or 50 of one endof the sheath 44 is threaded through the opening 90 of the dilator 54and secured to the sheath 44, thereby forming a loop. Optionally, aconnector 8 may be used to secure the loop. The edge portion 48 or 50alternatively may be fastened onto the sheath 44 via ultrasonic welding,bonding, melting, suturing, sealing or other attachment techniques.Further, as shown in FIG. 23, the end 52 of the dilator 54 preferablyincludes a cut-away section 94 to provide room to receive sling assemblymaterial to reduce the overall profile of the sling assembly experiencedby tissue during sling passage. Therefore, when the sheath is attachedto the cut-away section, the additional sheath material is not apt tosignificantly increase the relative thickness, diameter or profile ofthe dilator 54.

As shown in FIGS. 24 and 25, one or more sutures 6 may be threadedthrough hole 90 and used to connect a sling to the dilator. This givesthe surgeon the option to associate the dilator with a particular slingmaterial just prior to implantation. Optionally, a suture anchor article8D (FIG. 24) may be used to enhance the attachment of the suture 6 tothe sling material, particularly if the sling material is sensitive tosuture pull through (e.g. such as some cadaveric fascia).

Alternatively, for dilators 54 manufactured via molding techniques, theend of the sheath 44 may be encased within and secured to the second end52 of the dilator 54 during the molding process. In yet anotherembodiment, the end of the sheath 44 may be fixedly attached within alongitudinal slot located near the first end 52 of the dilator 44 usingan adhesive, ultrasonic welding or other attachment techniques.

Referring to FIGS. 23-26, the first end 56 of the dilator 54 includes asecond opening or through-hole or lumen 96 that extends substantiallyinternally along the longitudinal axis of the dilator 54. The hole 96preferably extends the length of the dilator 54.

The lumen 96 has an internal diameter generally configured forconvenient attachment to a needle 60 or similar sling-delivery device.In one embodiment, the internal diameter of the second opening 96 of thedilator 54 is approximately within the range of 0.239 cm to 0.318 cm(0.094 inch to 0.125 inch). A shoulder 98 located on the surface 100 ofthe second opening 96 of the dilator 54 and a complementary matingrecess located on the surface of the first end of the needle 60 securelyand permanently attach or lock the dilator 54 and needle 60 together.Once the needle 60 is inserted into the dilator 54, they are preferablynot separated thereafter. After the sling 42 is implanted, the connectedneedle 60 and dilator 54 are removed from the sling by cutting an end ofthe sling as described in greater detail below. Preferable, the needle60 and dilator 54 are discarded after the surgical procedure.

One or more longitudinal slots 102 located on the outer surface of thedilator 54 and in communication with the second opening 96 allow thewall of the dilator 54 to expand in a radially outward direction whenthe first end of the needle 60 is inserted into the second opening 96 ofthe dilator 54. When the shoulder 98 of the dilator 54 passes the recessof the needle 60, the wall of the dilator 54 collapses around the needle60 as the shoulder 98 seats into the recess, thereby securing thedilator 54 on the needle 60 and blocking separation of the dilator 54and needle 60.

Although the invention has been described in terms of a shoulder 98 andmating recess, alternative dilator-needle attachment mechanisms such asbumps, grooves, slots, wedges, detents and other mechanisms are alsoincluded within the scope of the claimed invention. The dilator 54preferably includes one or more relief ports 104 to facilitateconvenient needle connection. The relief ports 104 may be formed at theends of the longitudinal slots 102 or at various high-resistancelocations along the dilator 54. The relief ports 104 decrease therigidity or resistance of radially outward expansion of the dilator walland, reduce the amount of force required to insert or securely attachthe needle 60 to the dilator 54. In yet another embodiment, superficialbands or rings, arc-shaped slots, superficial grooves or othermechanisms may provide improved expansion or attachment characteristics.

A portion of the dilator 54 includes a taper 88 having a decreasingprofile toward the second end 56 of the dilator 54. The taper 88preferably gently cams tissue out of the path of the sling assembly 46as the sling assembly is inserted in the body. The taper 88 is alsosized and shaped to reduce the amount of friction or resistance as thedevice is drawn through the tissues of the patient. The amount of forcerequired to manipulate the device through the tissues is therebyreduced. This in turn provides the user of the assembly with additionalcontrol over device insertion and maneuverability through tissue andwithin the patient. In addition to tapered profiles, other dilatorprofiles such as conical, flared, frusto-conical, pyramid-shaped,elliptical or other applicable profiles may also be used. Overall, theprofile of the dilator 54 is preferably configured to provide easydilation of the tissue to accommodate smooth passage of the sling42/sling assembly 46 and subsequent collapse of the surrounding tissueto securely anchor the sling 42 into the tissue (after sheath removal).

In other embodiments of the invention, shown in FIGS. 18 and 18A, adilator 54A or 54B includes a sling fastening snap mechanism 106 or 106′on one end of the dilator. The embodiment disclosed in FIG. 18A includesa keyed/locking mechanism on its other end. Referring to FIG. 18, theend of the dilator 54 a includes a slot or slot-shaped opening 110configured for convenient insertion of one end of a sling 42 (such asone made from non-synthetic tissue) or sling assembly 46 (e.g. ofsynthetic materials) either at the surgical site (e.g. by the operatingroom nurse or surgeon) or other location (such as manufacturinglocation). Additional shapes for the dilator opening 110 include,without limitation, oval, circular, square, rectangular and othershapes. The slot-shaped opening 110 is located along a portion of thelongitudinal axis of the dilator 54A.

Referring to FIG. 18A, snap-like element 112′ is located on an outersurface near the first end of the dilator 54B. The snap-like element112′ includes a barb or spike 114 that fits within an opening 116situated near the first end of the dilator 54B. The opening 116 for thebarb 114, preferably configured perpendicular to the slot-shaped opening110′, is sized and shaped to match or mate with the barb 114 of thesnap-like element 112′. When the barb 114 is fully seated within theopening 116 of the dilator 54B, the tip 118 of the barb 114 extends intothe slot-shaped opening 110′ of the dilator 54B. A first ridge 120 and asecond ridge 122 located along the length of the barb 114 further secureand/or fasten the barb 114 within the opening 116 of the dilator 54B.Other fastening configurations including, but not limited to, bumps,shoulders, tabs, detents, tongue in grooves, snaps and any combinationsof fastening means may also be used with the present invention.

During use, one end of the sling (e.g. 10 or 42, in FIG. 1), sheath 44or sling assembly 46 is inserted into the slot 110′ of the dilator 54B.With the end of the sling 42/sling assembly 46 properly positionedwithin the slot 110′, the barb 114 of the snap-like element 112′ isinserted into the opening 116 of the dilator 54B. The barb 114 is fullyseated within the opening 116 when both ridges 120, 122 pass through theopening 116 of the dilator 54B. This causes the tip 118 of the barb 114to bear down on or penetrate a portion of the sling 42/sling assembly 46extending within the slot 110′ of the dilator 54B, thereby securelyfastening the sling 42/sling assembly 46 to the dilator 54B.

A keyed/locking mechanism 108 is located near the second end 56B of thedilator 54B. As shown in FIG. 18A, a square-shaped opening 124 extendsalong a portion of the longitudinal axis near the second end 56B of thedilator 54B. The shape of the dilator opening 124 matches thesquare-shaped perimeter of the keying-segment 126 located near the firstend 58 of the needle 60 and allows keyed-rotation of the dilator 54B atninety-degree intervals. Other appropriate shapes for the dilatoropening 124 may also be used provided that the shape of the opening 124complements the corresponding keying-segment shape located near thefirst end 58 of the needle 60. When the first end 58 of the needle 60 ispositioned within the dilator 54B, the square-shaped opening 124 of thedilator 54B together with the keying-segment 126 of the needle 60prevents axial rotation of the dilator 54B relative to the needle 60and, thus, twisting of the sling 42/sling assembly 46. This optionalfeature provides the practitioner or user of the assembly with controland maneuverability of the assembly before and during the insertionprocedure.

The dilator 54B also includes a locking mechanism 128. Referring to FIG.18A, the locking mechanism 128 comprises one or more tension-loaded ribslocated within the longitudinal opening of the dilator 54B. Theconfiguration of the ribs generally matches and corresponds to acomplementary recess 130 located near the first end 58 of the needle 60.Thus, the first end 58 of the needle 60 is inserted through thelongitudinal opening 124 of the dilator 54B until the ribs of thedilator 54B seat within the recess 130 of the needle 60. The dilator 54Bis securely attached or locked onto the needle 60 when the dilator ribsare fully seated within the needle recess 130.

Referring to FIG. 18B, in an alternate embodiment of the invention, thesheath 44 (or sling 42 or 10 or assembly 46) is attached to the dilator54C via a locking (or compression) collet 132 and adapter connector 134.The compression collet 132 comprises a ring-shaped portion 136 havingone or more barbed snap tongs 138. The complementary adapter 134comprises a cylindrical element 140 having a first end 142 and a secondend 144. The internal profile near the first end 144 of the adapterconnector 134 includes a tubular lumen or channel 146, having one ormore recesses, shoulders, grooves or similar indentations 148,surrounding an internal prong 150. The second end 144 of the adapterconnector 134 includes one or more barbed snap tongs 152, similar to thetongs 138 of the compression collet 132. In addition, the first end 52Cof the dilator 54C includes a longitudinal opening 154 having one ormore recesses, grooves, slots or related types of indentations 156configured to engage the tongs 152 of the adapter connector 134.

In use, one end of the sling (e.g. 10 or 42/sling assembly 46) of thepresent invention is configured into a tubular or appropriate shape thatenables a sufficient portion of the end of the sling 42/sling assembly46 to be inserted through the compression collet 132. The tongs 138 ofthe compression collet 132 are then inserted into the first end 142 ofthe adapter connector 134, causing the tongs 138 to snap into engagementwith the adapter connector 134. The end portion of the sling 42/slingassembly 46 is compressed between the tongs 138 of the compressioncollet 132 and the internal prong 150 of the adapter connector 134,thereby securely fixing the sling 42/sling assembly 46 to thecollet/adapter assembly. In a similar fashion, the tongs 152 of theadapter 134 are then inserted and snap-locked into the first end 52C ofthe dilator 54C, creating a secure fixation between the collet/adapterassembly and dilator 54C. Alternatively, a non-synthetic sling 10 couldreplace sling 42 in this embodiment of the present invention.

In another aspect of the present invention, a dilator or adapter neednot be present. Referring to FIGS. 22 and 22A, there are shown slingassemblies that may optionally be free of adapters or dilators accordingto additional embodiments of the present invention.

FIG. 22 illustrates a sling assembly 240 for implantation without theneed to use bone anchors or screws. The sling assembly 240 comprises asynthetic surgical mesh 42A (e.g. a polypropylene surgical mesh) havinga plurality of holes. The holes are preferably sized and shaped toafford tissue ingrowth. The synthetic surgical mesh is sized and shapedto be implanted during a surgical sling procedure.

Some synthetic mesh used for slings are relatively extensible. Unlikecadaveric fascia and other non-synthetic materials which tend to berelatively slippery, an extensible sling mesh may be difficult to threadthrough tissue alone. Also, even if such slings could be inserted alone,some synthetic slings could be damaged during insertion, or could damagetissue. A removable synthetic insertion sheath 44A (e.g. polyethylene)is situated about the surgical mesh to assist in inserting the slingmesh 42A.

The insertion sheath has first and second ends. In the embodiment shownin FIG. 22, at least one suture 6A is associated with the insertionsheath 44A and extends beyond the first end of the insertion sheath 44Aa length sufficient to afford attachment of the sling assembly to aneedle. At least one other suture 6A is associated with the insertionsheath 44 and extends beyond the second end of the insertion sheath 44Aa length sufficient to afford association of the sling assembly with aneedle. Sutures 6A may be associated with sheath 44A via knotting,suture anchor, tying, weaving, bonding, ultrasonic welding or otherattachment techniques, including combinations thereof, to prevent suture6A detachment during and/or following sling implantation. The sling 42Amay optionally be associated with the sheath 44A through suchtechniques.

The suture 6A can be attached to the needle by a multitude ofapproaches, such as being tied, knotted, or placed in a suturepassageway and retracted into the needle as described above. Forexample, the straight needle shown in FIGS. 9, 9A and 10 could be usedto implant the sling assembly 240. In use, the needle 80 is insertedsuprapubically and emerges from the body through a vaginal incision. Thebutton 88 can then be extended to expose the suture accept hole 82 andthe suture 6A can be passed through hole 82 and tied. The tied suturecould then be retracted within the sheath 87 by manipulating button 88.The needle 80 could then be pulled up through the body to implant thesling 240. Alternatively, a stock ligature carrier could be used insteadof needle 80.

Optionally, the suture 6A could be tied to a dilator or other componentof a needle assembly as shown in FIG. 34. Preferably, the insertionsheath 44A defines an interior portion that includes the surgical mesh,and an exterior portion, and the sutures 6A that extend beyond the firstand second ends of the insertion sheath 44A are completely situated onthe exterior portion of the sheath. Also preferably, the insertionsheath 44A is securely attached to the sling 42A, by a means such asultrasonic welding, suturing or adhesive. A tensioning member 66 mayoptionally be provided.

FIG. 22A illustrates another embodiment of a sling assembly 250 for usein an incontinence procedure. The sling assembly 250 is particularlysuitable for implantation without bone anchors and need not include adilator or adapter. The sling assembly comprises a synthetic surgicalmesh 42D having first and second ends and a plurality of holes that aresized and shaped to afford tissue ingrowth. The synthetic surgical mesh42D is preferably sized and shaped to be implanted during a surgicalsling procedure designed to treat incontinence in females. It may besized and shaped to be placed mid-urethra in a tension free fashion totreat SUI. It may be long enough to extend from the patient's abdominalfascia to the patient's urethra and back again or it may be shorter andutilize sutures 252 for anchoring in the abdominal fascia.

The sling assembly 250 includes a removable synthetic insertion sheath44D situated about the surgical mesh 42D. At least one suture 252 isassociated with the surgical mesh 42D and extends beyond the first endof the surgical mesh 42D. Preferably the suture 252 has a lengthsufficient to afford attachment of the sling mesh 42D to a needle.Another suture 252 is operatively associated with the surgical mesh andextends beyond the second end of the surgical mesh a length sufficientto afford attachment of the mesh to a needle. Sutures 252 may beoperatively associated with the mesh 42D in a variety of fashions (e.g.by tying, knotting, weaving, adhering, or welding). Alternatively, asuture anchor or pledget may be used to anchor the sutures 252 to themesh 42D.

Preferably, the insertion sheath 44D defines an interior portion thatincludes the surgical mesh 42D, and an exterior portion. Suture 252preferably extends beyond the first end of the surgical mesh and extendsfrom the interior portion of the sheath 44D to an exterior portion ofthe sheath 44D.

Optionally, sutures 6D may be tied to the end of the sheath 44D.Preferably, sutures 6D are provided in a different color than sutures252. Alternatively, sutures 6D can be omitted and sutures 252 can betied to external portions of the sheath 44D.

The sutures 252 may optionally be anchored to tissue in the body (e.g.the abdominal rectus fascia) to help secure the sling. In thisembodiment, it is preferred that the sutures 252 are of a differentcolor than sutures 6D.

Referring now to FIGS. 1 and 19, there is shown another aspect of thepresent invention. In this embodiment, the present invention comprises asurgical kit for treating incontinence. The kit comprises an implantablematerial (e.g. 10), and a needle 60. The needle 60 has surfaces forengaging a handle. The kit also includes at least one of a first type ofhandle 64 having surfaces for attaching the handle to the needle 60, andat least one of a second type of handle (e.g. see FIG. 19) havingsurfaces for attaching the handle to the needle 60.

As used in this application, when it is said that one handle is adifferent type than another handle, it is meant that the handlessubstantially differ in a feature that can potentially affect a surgicalprocedure for treating a urological disorder. Features that can bedifferent according to the present invention include the size of thehandles, the shape of the handles, the materials used to construct thehandles, the presence, absence or location of finger indents, whetherthe handle is movable, whether the handles are repositionable, whetherthe handles are releasable, whether the handle can be indexed between aplurality of positions, and the location of operable elements. Thehandles may have any of the structure and features described in U.S.patent application Ser. No. 09/917,443 filed Jul. 27, 2001 (the entirecontents of which are herein incorporated by reference).

FIG. 19 illustrates a plurality of different types of handles. Handle 22comprises a slim, elongate structure with a button near the proximalend. Handles 31, 35, 37 and 39 have an operable member (e.g. button)near the distal end of the handle. Handle 31 is rounded, while handles33, 35, 37 and 39 are elongate. The handles may be movable relative to aneedle (e.g. slidable or rotatable), repositionable on a needle (e.g. itmay be indexed between different positions) and/or replaceable on aneedle (e.g. moved from one end to the other end of the needle).

FIGS. 15-16 show needles 202 and 204 with integral handles. FIG. 5illustrates a first handle 64B and a second handle 64′ that may beplaced on the same needle 60B.

FIG. 20 illustrates a handle 172 that may be attached to a needle 60.The handle 172 includes a strengthening portion 174 designed tostrengthen the needle 174. The handle 172 optionally includes releasableattachment means 177 for releasably attaching the handle 172 to theneedle 60. The handle 172 is particularly useful when the needle 60includes a relatively small cross sectional area or is relativelysusceptible to bending during an anticipated procedure. A kit with thehandle 172 enables the surgeon to place the handle 172 on the needle 60to avoid bending, twisting or other deformation of the needle 60 duringthe surgical procedure.

Instead of a hole 90 in the dilator 54, another mechanism may beutilized to connect a dilator 54 to a surgical sling material, sheath orsling assembly. FIGS. 41 and 43 illustrate an adapter 54I. One end ofthe adapter includes a mechanism for attaching to a needle 60. The otherend of the adapter 54I includes a means for attaching to a sling 10. Themeans for attaching to a sling includes jaws 366 movable between an openposition (FIG. 41) for receiving the sling 10 and a closed position (seeFIG. 43) for firmly holding the sling 10 and resisting separation of thesling 10 from the adapter 54I.

A fastening arm 365 with securement flange may fit in a hook shapedreceiving slot 364 within adapter 54I. Optionally, a spring (not shown)may be utilized to bias the securement flange to the end of the hook toresist separation of the jaws 366 from the remaining portion of theadapter 54I. When the fastening arm 364 is fully inserted in the slot364, inner surfaces of the adapter 54I engage outer surfaces of the jaws366 to retain the jaws 366 in the closed position and to block movementof the jaws toward the open position. Secure association between thejaws 366 resists undesirable separation of the sling 10 and the adapter54I within the body of the patient.

FIG. 42 illustrates another portion of an adapter. The element shown inFIG. 42 includes jaws 359, and threads 357 that can be screwed intocomplementary threads in an adapter. The jaws 359 include a piercingmember 353 that can penetrate through sling or insertion sheath 44.Preferably the piercing member 359 includes an enlarged end portion thatcan retain the jaws 359 in a closed position and can block separation ofthe sling material. The piercing member is a positive barrier toseparation between the jaws 359 and the sling or insertion sheath 44.

Operating theatres often stock specialized surgical needles that arecommonly used by urologists. Such needles include Stamey, Raz, andPereyra needles. FIGS. 27 and 27A illustrate a needle converter 712 thatcan exploit a surgeon's comfort in using a stock needle.

FIG. 27A shows a sling assembly comprising a sling mesh material 42 anda dilator 54. An optional sheath 44 is also shown. The sheath 44 isthreaded through hole 90 and attached to itself (e.g. by ultrasonicwelding). The dilator 54 has an end portion (opposite the end near hole90) with a passageway. The passageway in the dilator (best seen in FIG.26) includes surfaces for receiving a first type of needle (e.g. 60).

Preferably, the surgical kit that includes needle converter 712 wouldalso include a needle 60. Needle 60 has an end portion that is sized andshaped to engage complementary surfaces in the passageway of the dilator54 to associate the needle with the sling assembly. However, for avariety of reasons, a particular surgeon may eschew the use of a firsttype of needle (e.g. 60) and instead opt to use a commonly available,standard needle (e.g. a Stamey needle 204 having a hole). Such a surgeonmay utilize the needle converter 712.

The needle converter 712 includes a first end portion having surfaces126D and 130D that are sized and shaped to engage complementary surfacesin the passageway of the dilator to associate the needle converter 712with the dilator 54. Surfaces 126D and 130D are substantially the sameshape as surfaces 126 and 130 of needle 60 (see FIG. 4). The needleconverter 712 has a second end portion that is opposite the first endportion. The second end portion has a means for attaching the needleconverter 712 to a second type of needle (e.g. Stamey needle 204) thatis different than the first type of needle 60.

The connection to the second type of needle can take a variety ofshapes. A plurality of needle converters can be supplied in the samesurgical kit. FIG. 27 shows the needle converter 712 in an unassembledcondition. The needle converter includes a leaf spring 710 with alocking pin, a locking sleeve 720 and a slot 718 for receiving the endof the second type of needle 204.

The locking pin of leaf spring 710 is preferably movable between aneedle accept position (FIG. 27) that allows the needle 204 to beinserted in the needle converter, and a needle engaged position (FIG.27A) with the locking pin firmly and securely attached to the needle204. The locking sleeve 720 is moveable between a needle accept position(FIG. 27) and a blocking position (FIG. 27A) that retains the lockingpin of leaf spring 710 in the needle engaged position. Preferably, aleading end of the locking pin of leaf spring 710 is angled to cam theleaf spring to the needle accept position when the end of needle 204 isslid into slot 718. An inherent bias of the leaf spring 710 preferablycauses the locking pin to move to the needle engaged position and fullyseat in the hole in needle 204 when the needle 204 is fully inserted inthe converter 712.

FIG. 27A shows the needle converter 712 in an assembled condition. Thelocking pin of the leaf spring 710 is seated in a hole in the secondtype of needle 204. The locking sleeve 720 has been slid in thedirection of the arrow in FIG. 27 to encompass the leaf spring 710 andto prevent the locking pin from moving out of engagement with the holein needle 204. Sleeve 720 is preferably blunt with rounded surfaces toresist damage to the patient while it is pulled through the body.Notably, resistance by the body while the sling assembly 42, 44 ispulled through the body will tend to urge the locking sleeve 720 towardthe blocking position to resist separation of needle 204 and needleconverter 712.

A surgical kit according to the present invention may optionally includeadditional accessories. FIG. 39 illustrates a cystoscopy aid 12. Thecystoscopy aid 12 may be inserted over a thin needle 60. The cystoscopyaid includes one or more apertures or perforations 160, that function tofacilitate verification of bladder and urethra integrity, are disposedalong the length of the cystoscopy aid 12. For example, during use,after the needles 60 have been inserted within the patient, thecystoscopy aid 12 may be pushed along the exterior surface of eachneedle 60. If the bladder has been punctured during needle insertioncausing urine leakage or drainage within the patient, the urine orbladder fluid will enter the apertures 160 of the cystoscopy aid 12 andflow along the surface and out from the needle 60. This allows thepractitioner to quickly and easily confirm urethra and bladderintegrity.

Other accessories may also optionally be included in a kit according tothe present invention. For example, a surgical drape specificallydesigned for urological procedures such as a sling procedure may beincluded in a kit of the present invention. Such a drape is disclosed inU.S. patent application Ser. No. 09/749,254, filed Dec. 27, 2001 (theentire contents incorporated herein by reference). Alternatively, anarticle for objectively setting tension of the device, such as thosedescribed in U.S. patent application Ser. No. 09/968,239, filed Oct. 1,2001 (the entire contents of which are incorporated by reference) may beincluded in the kit.

Other accessories may also be included for convenience. For example, ifa needle includes an optical feature, then a optical elements may beincluded. If a needle includes a resistance detector, then the kit mayinclude a means for detecting a bladder perforation due to the change inresistance encountered by a needle due to a bladder puncture.

The kits according to the present invention preferably include at leasttwo needles. Two or more needles reduce the need to reuse a needle at adifferent location with a patient, thereby eliminating crosscontamination issues. Additional needles, handles, dilators and otherelements may also be included for surgical convenience, for avoidance ofcontamination from one portion of the body to another, for ease ofmanufacturing or sterilization or for surgical requirements.

The individual elements of the kits of the present invention may bepackaged together, separately or in subassemblies depending on a varietyof factors such as shelf life and sterilization requirements. They maybe assembled at the manufacturing location or at the healthcarelocation. Any suitable sterilization procedure may be utilized tosterilize the contents of a kit. Suitable sterilization techniquesinclude, but are not limited to steam, ethylene oxide, electron beam,vapor (e.g. hydrogen peroxide or peracetic acid), or plasma procedures.

Examples of Surgical Procedures

Several methods are contemplated herein. Although the methods of use asdisclosed herein generally relate to female incontinence conditions andtreatments/procedures, male incontinence conditions andtreatments/procedures are also included within the scope of the presentinvention. Procedures that address problems other than incontinence(e.g. cystocele, enterocele or prolapse) are also contemplated alone orin conjunction with the present invention. Further, the term “urethra,”with respect to sling positioning, is used for brevity and readerconvenience. It should be noted that the present invention isparticularly suitable for placing a sling in a therapeutically effectiveposition. The method may be utilized to support a variety of structuresat different anatomical locations. As such, the terms “target site,”“bladder”, “urethro-vesical juncture”, “vaginal vault”, “U-V juncture”and “bladder neck” are also included within the scope of the presentinvention.

The present invention includes surgical procedures that utilize thenovel surgical instruments, articles and kits described above. Thepresent invention also includes improved surgical sling procedures.

Referring now to FIGS. 1A and 28, there is shown a first embodiment ofmethod according to the present invention. The method includes step 292of providing a surgical kit with an implantable material (e.g. a slingmesh from sling assembly 46), at least one of a first type of needle(e.g. needle with curved portion 60), and at least one of a second typeof needle (e.g. straight needle 60A).

The method also includes step 294 of selecting the first 60 or thesecond 60A type of needle. Next, in step 296, a decision is made as towhether the needle is initially placed through an abdominal incision andthen through a vaginal decision (e.g. a suprapubic approach). If thesuprapubic approach is utilized, the needle is inserted in the body instep 291, a sling is then associated with a portion of the needleextending through a vaginal incision in step 293. The sling is implantedin step 295. After the sling is implanted, the incisions are closed atthe end of the procedure (step 287).

Alternatively, step 298 may decide that the needle will be initiallyinserted in a vaginal incision and then passed through an abdominalincision (a suprapubic approach). If an optional removable handle isused, in step 297, it may be desirable to initially associate the handlewith the needle and then insert the needle in step 291. If no removablehandle is used or once it is removed, the sling may then be associatedwith the needle (e.g. step 289) used in the transvaginal approach. Theneedle is inserted (e.g. step 283), the sling is implanted (step 281),incisions are closed and the procedure ends 288.

The present invention preferably utilizes a suprapubic approach. Asuprapubic approach affords greater control over the end of a needle toavoid areas with sensitive vascular structures and the obturator nerves.Further the heightened control associated with a caudad passage isbelieved to avoid injury to bowel tissue.

Additional methods according to the present invention are shown in FIGS.1, 2, 21 and 29. Referring to FIGS. 1 and 29, another method accordingto the present invention comprises the steps providing a surgical kit312 having a first type of sling material (e.g. a synthetic materialassociated with sling assembly 46), a second type of sling material(e.g. a different type of synthetic sling material or a non-syntheticsling 10), and a surgical instrument (e.g. needle 60) for implanting asling material. The method includes step 314 of selecting the first typeof sling material or the second type of sling material, step 320 ofassociating the sling with the needle 60, and step 322 of implanting thesling material with the needle 60.

The method may optionally include the steps of constructing orassembling the sling from the plurality of sling material types. Step316 decides whether a sling should be constructed or whether apre-existing sling may be used. If it is decided that a hybrid slingneed not be assembled (i.e. that synthetic sling assembly 46 could beused alone), then sutures 6 and the mechanical fastener (e.g. grommet 8)may be used to attach a sling assembly 46 to dilator 54.

Notably, non-synthetic sling materials typically include storage andsterilization requirements quite different than synthetic slings. As aresult, non-synthetic slings are preferably not packaged with syntheticslings due to considerations such as shelf life. Referring to FIG. 2, amechanical fastener (e.g. grommet 8) may be included in a surgical kitto enable a bulk non-synthetic sling material 14 to be cut and assembledto a synthetic sling material 42. As a result, a surgeon has the optionof constructing a hybrid sling according to an aspect of the presentinvention.

A surgeon may desire to assemble a hybrid sling for a variety ofreasons. For example, some sling materials may be believed to be lesslikely to erode sensitive tissue such as the urethra. Silicone coatedslings and non-synthetic slings may be believed to be less likely toerode the urethra than some synthetic slings. Additionally, somesynthetic slings may be more likely to encourage tissue ingrowth. As aresult, as shown in FIG. 2B, the surgeon may wish to assemble a slingwith a mid portion made of one type of sling material and anotherportion made of another type of sling material. Other factors may alsoinfluence the surgeon's decision, such as previous failure of aparticular type of sling material, the existence of scarring or otheranatomical characteristics of a patient, and the influence ofconcomitant procedures.

Referring now to FIGS. 21 and 30 through 37, a preferred embodiment ofsurgical procedure is disclosed. Initially, the patient is placed underlocal, spinal or general anesthesia A small transverse incision 404 ismade in the anterior vaginal wall 20 of a female patient followed by atransurethral dissection. Two small transverse suprapubic abdominal stabincisions 400 are also made near the back of the pubic bone (e.g. eachabout 1 cm from the midline, or alternatively, one large incision may bemade) to allow for needle entry. Optionally, two paraurethraldissections (incisions next to the urethra) lateral to the midline maybe created to allow the surgeon's finger to meet the end 58 of theneedle 60 during the procedure.

A handle 64 is optionally adjusted relative to needle 60 according tosurgeon preference and securely associated with the end 62 of the needle60. FIG. 30 shows the end 58 of needle 60 just passing an abdominalincision 400. Preferably, after the end 58 of the needle 60 passes thesuprapubic abdominal incision 400, the surgeons seeks to encounterresistance associated with the posterior portion of the patient's pubicbone 402 with the end 58 of the needle 60 to controllably move the end58 of the needle toward the vaginal incision 404 and to help avoiddamaging structures such as the urethra and bladder of the patient. Theend 58 of the needle 60 is used to identify the location of the pubicbone 402. The surgeon exploits the resistance provided by the pubic bone402 to controllably pass the end of the needle 58. This approach ispreferred as it helps keep the needle 60 away from major pelvic vessels,nerves and anatomical structures such as the urethra, bowels andbladder.

FIG. 31 illustrates the end of the needle as it just passes thesuprapubic incision. FIG. 32 illustrates the needle 60 as the surgeonexperiences the tactile feel of the resistance provided in part by theposterior portion of the pubic bone 402. FIG. 32 shows the needle 60 asit passes in proximity to the posterior surface of the pubic bone 402which continues to operate as an anatomical guide for the surgeon as theneedle end 58 approaches vaginal incision 404 (see FIG. 33).

FIG. 33 illustrates the needle as it passes out of a vaginal incision404. Optionally, with the index finger of a hand, the surgeon may meetthe end 58 of the needle via the paraurethral dissection. The surgeon'sfinger may be delicately placed adjacent endopelvic fascia of thepatient and used to guide the needle 60 through the relatively toughendopelvic fascia and into the vaginal incision 404. This helps thesurgeon keep away from structures such as the bladder, urethra and othersensitive tissue.

The small diameter and curvature of the needles 60 help to provideprecise passage of the needles 60 to the vaginal incision 404. Inaddition, this needle configuration creates a minimally invasive pathwaythrough tissue extending between the abdominal wall and pubic space,thereby reducing the risk of perforating the bowel and/or blood vesselsand nerves located lateral to the bladder 14.

The steps described above are repeated as needed for a second needle 60on the other side of the urethra 16. Once both needles are placed,surgeons typically perform a cystoscopy to ensure that the bladder isnot punctured before implanting the sling. A cystoscopy confirms theintegrity of the bladder 14 and urethra 16 or recognizes a bladderperforation. The plastic cystoscopy aid shown in FIG. 39 may optionallybe used for this purpose. The cystoscopy aid may be used separately orin conjunction with cystoscopy.

FIG. 34 is a perspective view of a sling system associated with twoneedles 60. Optional adapters (e.g. dilators 54) are pushed onto theends 58 of needles 60 as shown in FIG. 34. The dilators 54 arepreferably snapped irreversibly into place for a secure connection.Next, if a synthetic sling assembly (such as the sling assembly of FIG.22) is used, the plastic sheath 44A is oriented so that the optionalcenter orientation indicia (e.g. a blue mark) is facing away from thesurgical field, toward the surgeon

After the dilators 54 are attached to the needles 60, the sling assembly46A is properly oriented so that the sling assembly 46A is not twistedwhen attached to the dilators 54. After the dilators 54 and slingassembly 46A are properly positioned, the dilators 54 are securelyattached to the sling assembly 46A by tying sutures 6 through holes 90so that none of the assembly separates as the needles 60, dilators 54and sling assembly 46A are pulled through the tissues of the patient.Alternatively, the sling assemblies 240 and 250 could be associated withdilators 54 by tying any of sutures 6A, 6D or 252 to the holes 90 ofdilators 54. Alternatively, the sling assembly 46 (FIG. 2) may include aloop 48 that is threaded through hole 90 and secured via mechanicalfastener 8. A sling assembly that includes a sheath and sling material(e.g. 42) preassembled to the dilator 54 is also within the scope of thepresent invention. Additionally, it is noted that the dilator 54 iscompletely optional and that instead, the sutures (e.g. 6, 6A, 6D or252) could be tied directly to a needle (e.g. 80 or stock ligaturecarrier) without the necessity to include the adapter/dilator 54.

Once the dilators 54 are securely attached, the needles are pulled upthrough the suprapubic incisions, taking care to avoid contact withsensitive tissue. The sling is then clamped with surgical clamps (notshown). During this portion of the process, the attached dilators 54 andsling assembly 46A are atraumatically pulled up through the needlepaths, advancing the sling assembly 46A adjacent to and looped beneaththe urethra 16 or target site. A portion of each end of the slingassembly 46A extending beyond the suprapubic incisions 400 is clampedand then cut to release the needles 60 and attached dilators 54.

The sling is placed in a therapeutically effective position. The preciseanatomical position will depend upon a variety of factors including thetype and degree of anatomical damage or insufficiency, whether the slingprocedure is combined with other procedures and other surgeon decisions.Typically, the sling is placed midurethra, without tension, but inposition to support the midurethra. Alternatively, the sling could beplaced to support the bladder neck and/or V junction.

Once the sling assembly 46A is carefully positioned under the midurethraor target site to provide sufficient support to the target site, theoverlapping portion of the sheath 44A located near the center of thesling assembly 46A and optional member 66 (i.e. tensioning filament) maythen be used to center and properly position the sling assembly 46Aunder the midurethra. The sheath 44A is then removed.

FIG. 35 shows the sling being tightened during the surgical procedure.Sling tension may be tightened by placing a device, such as a clamp,across one or both ends of the sling 42, suprapubically. Generally, thesurgeon grasps the mesh and tensioning filament together adjacent thesuprapubic incision 400 and pulls to increase the degree of tightness ofthe mesh. FIG. 35 shows the sling after the dilators have been cut off,but prior to final trimming.

After the dilators 54 are trimmed off, the plastic sheath 44A is removedfrom the sling mesh 42A by pulling up on both sides of the sheath 44A,preferably one at a time. Optionally, to avoid overtightening the slingmesh 42A while removing the sheath 44A, a forceps or other bluntinstrument may be placed between the sling and the urethra.

In another embodiment of the invention, shown with reference to FIG. 38,a method includes the steps of: providing a surgical kit comprising atleast one guide needle 602 with a relatively small diameter (e.g. lessthan 4 mm), and at least one sling transport needle 604 with a sharptip, a sling 610 attached to the sling transport needle 604, and anadapter (e.g. dilator 54) having tip receiving surfaces (e.g. an end ofinnerpassageway 96 near end of the dilator having hole 90) for receivingthe sharp tip of the sling transport needle 604. For example, the slingtransport needle 604 and sling 610 may comprise a TVT needle and slingavailable from Ethicon of New Jersey.

The method includes the steps of creating at least one vaginal incision404, creating at least one suprapubic incision 400, and initiallypassing the guide needle 602 through the suprapubic incision 400 andthen through the vaginal incision 404, and associating or attaching theadapter 54 to the needle 602 (preferably after but optionally beforepassage of the needle 602 from the suprapubic incision to the vaginalincision 404).

Needles 604 are initially passed through a vaginal incision 404 andtoward one of the suprapubic incisions 400. While inserting the needles604 initially through the vagina is not preferred, it is within thescope of the present invention as some surgeons may prefer this approachdue to previous surgical training, custom or personal preference. Themethod includes the step of placing the sharp tip of the sling transportneedle 604 in the tip receiving surfaces of the adapter 54, and thenguiding the sling transport needle 604 from the vaginal incision 404 tothe suprapubic incision 400 with the guide needle 602 to implant thesling 610. Handle 620 may be connected to sling attachment end of needle604 for this purpose. Guiding the sharp tip of the large sling transportneedle 604 in this fashion is believed to help avoid contact between thesharp tip of needle 604 and sensitive structures such as obturatornerves, and vascular structures such as the superficial epigastricvessel, the inferior epigastric vessel, the external iliac artery andthe obturator. Optionally the adapter with receiving surfaces may beintegrally formed in the needle 602 to avoid the need to separatelyattach the adapter to the needle 602. Also optionally, the adapter andsling transport needle 604 may include complementary engagement surfacesfor securely attaching the needle 602 to the needle 604.

In another aspect of the present invention, a needle dilator or adaptermay not be needed in a surgical procedure. For example, the proceduremay utilize a sling assembly that includes a suture extending from theend of the sling assembly (e.g. a sling as described in conjunction withFIG. 22 or 22A). The method includes the steps of: i) providing thesling, ii) creating at least one vaginal incision, ii) creating at leastone suprapubic incision, iii) passing a leading end of a needleinitially through a suprapubic incision and then through the vaginalincision on one side of the patient's urethra, iv) passing a leading endof a needle initially through a suprapubic incision and then through thevaginal incision on the other side of the patient's urethra, v)attaching the first suture to the leading end of a needle, vi) attachingthe second suture to the leading end of a needle, vii) implanting thesling by moving the leading end of a needle from the vaginal incisiontoward a suprapubic incision, and viii) then removing the syntheticinsertion sheath. In one embodiment, the needle may comprise a needle orligature carrier (e.g. such as needle 80 shown in FIGS. 9, 9A and 10)that includes a retractable suture holder for securely holding thesuture to the needle while the needle and sling assembly are drawn upthrough the body. A single needle (e.g. the same needle 80 used on bothsides of the urethra) or two needles could be used in this embodiment ofsurgical procedure.

Although the invention has been described in terms of particularembodiments and applications, one of ordinary skill in the art, in lightof this teaching, can generate additional embodiments and modificationswithout departing from the spirit of or exceeding the scope of theclaimed invention. Accordingly, it is to be understood that the drawingsand descriptions herein are proffered by way of example to facilitatecomprehension of the invention and should not be construed to limit thescope thereof.

1. A sling system for treating a pelvic condition in a patient,comprising: a sling assembly including; an implant having a supportportion and one or more extension portions a tissue penetration enddevice; a needle device to facilitate deployment of the sling assemblywithin the patient including; a needle having an interior lumen and anelongate member having a distal end and movable with the interior lumen,wherein the elongate member includes a snap engagement feature toselectively engage the tissue penetration end device; and a handlehaving an actuation mechanism, the actuation mechanism having anactuator and a biasing member in operable communication with theelongate member, wherein the biasing member biases the elongate memberin an extended position a distance out from the elongate needle, and theactuator is adapted to retract the elongate member within the needle. 2.The sling system of claim 1, further including visual indicia tofacilitate centering a portion of the implant relative to target supporttissue.
 3. The sling system of claim 1, further including a sheathhaving first and second portions adapted to overlap proximate thesupport portion of the implant.
 4. The sling system of claim 3, whereinthe sheath is made at least in part of a polymer material.
 5. The slingsystem of claim 1, wherein a portion of the needle device is curved. 6.The sling system of claim 1, wherein the implant is made of a porouspolymer mesh material.
 7. The sling system of claim 1, wherein thehandle is removable from the needle device.
 8. The sling system of claim1, wherein the needle is removable from the needle device.
 9. The slingsystem of claim 1, wherein the implant is an elongate mesh implant. 10.The sling system of claim 1, wherein the support portion is positionableunder a urethra or bladder neck of the patient.
 11. The sling system ofclaim 1, wherein the implant further includes a tensioning member. 12.The sling system of claim 11, wherein the tensioning member is atensioning filament.
 13. A sling system for treating incontinence in apatient, comprising: a sling assembly including; an elongate meshimplant having a central support portion and one or more extensionportions, an end dilator provided with at least one of the one or moreextension portions; a needle device to facilitate deployment of thesling assembly within the patient having an elongate needle having aninterior lumen, and an elongate member having a distal tip, the elongatemember adapted to move with the interior lumen, wherein the distal tipis snappingly engageable with the end dilator; and a handle having anactuator and a spring member in operable communication with the elongatemember, wherein the spring member biases the elongate member in anextended position a distance out from the elongate needle, and theactuator is adapted to retract the elongate member within the elongateneedle.
 14. The sling system of claim 13, further including visualindicia to facilitate centering a portion of the mesh implant relativeto target support tissue.
 15. The sling system of claim 13, furtherincluding a sheath having first and second portions adapted to overlapproximate the central support portion of the implant.
 16. The slingsystem of claim 15, wherein the sheath is made at least in part of apolymer material.
 17. The sling system of claim 13, wherein the implantfurther includes a tensioning member.
 18. The sling system of claim 13,wherein the handle is removable from the needle device.
 19. The slingsystem of claim 13, wherein the needle is removable from the needledevice.
 20. The sling system of claim 13, wherein the central supportportion is positionable under a urethra or bladder neck of the patient.